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Comparison of oral and intravenous lansoprazole for the prevention of bleeding from artificial ulcers after endoscopic submucosal dissection for gastric tumors: a prospective randomized phase II study (KDOG 0802)

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Abstract

Background

Very few studies have evaluated the effectiveness of oral proton-pump inhibitors for the prevention of bleeding after endoscopic submucosal dissection (ESD) for gastric tumors. The aim of our study was to establish the non-inferiority of lansoprazole orally disintegrating (OD) tablets to intravenous lansoprazole for the prevention of bleeding from artificial ulcers after ESD.

Patients and methods

Consecutive patients who underwent ESD for gastric tumors were randomly assigned to receive lansoprazole OD tablets (OD group) or intravenous lansoprazole (IV group). In the OD group, lansoprazole OD tablets (30 mg) were given orally once daily for 8 weeks (56 days), starting on the day before ESD. In the IV group, lansoprazole (30 mg) was given as a continuous intravenous infusion twice daily for 3 days, starting on the day before ESD, and lansoprazole OD tablets (30 mg) were given orally once daily on days 4–56. The primary endpoint was the incidence of bleeding events within 8 weeks after ESD.

Results

Among 310 enrolled patients, 304 patients (152 in the OD group and 152 in the IV group) were included in the analysis. Endoscopic hemostasis was performed in 38 patients (19 in the OD group and 19 in the IV group). The incidence of bleeding events within 8 weeks after ESD did not differ significantly between the groups (p = 0.487). Endoscopic hemostasis was performed at second-look endoscopy in 17 patients (11.2%) in the OD group and 19 patients (12.5%) in the IV group (difference, 1.3 percentage points; 90% confidence interval, − 4.8–7.4%; non-inferiority, p < 0.001).

Conclusions

The effectiveness of lansoprazole OD tablets for the prevention of bleeding from artificial ulcers after ESD was similar to that of intravenous lansoprazole. Lansoprazole OD tablets are thus considered a treatment option in patients who undergo ESD.

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Authors and Affiliations

  1. Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan

    Kenji Ishido, Mizutomo Azuma, Chikatoshi Katada, Takuya Wada, Takafumi Yano & Wasaburo Koizumi

  2. Research and Development Center for New Frontiers, Kitasato University School of Medicine, Sagamihara, Japan

    Satoshi Tanabe

Authors
  1. Kenji Ishido
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  2. Satoshi Tanabe
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  3. Mizutomo Azuma
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  4. Chikatoshi Katada
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  5. Takuya Wada
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  6. Takafumi Yano
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  7. Wasaburo Koizumi
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Corresponding author

Correspondence to Kenji Ishido.

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Disclosures

Drs. Kenji Ishido, Satoshi Tanabe, Mizutomo Azuma, Chikatoshi Katada, Takuya Wada, Takafumi Yano, and Wasaburo Koizumi have no conflicts of interest or financial ties to disclose.

Ethical approval

This study was conducted in accordance with the principles of the Declaration of Helsinki. The protocol was approved by the institutional review board of the participating hospital.

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Ishido, K., Tanabe, S., Azuma, M. et al. Comparison of oral and intravenous lansoprazole for the prevention of bleeding from artificial ulcers after endoscopic submucosal dissection for gastric tumors: a prospective randomized phase II study (KDOG 0802). Surg Endosc 32, 2939–2947 (2018). https://doi.org/10.1007/s00464-017-6008-9

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  • DOI: https://doi.org/10.1007/s00464-017-6008-9

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